Efficacy of Clomipramine for chronic lumbar radicular pain: A Randomized Clinical Trial
- Conditions
- Musculoskeletal Diseases
- Registration Number
- PACTR202001764151121
- Lead Sponsor
- El Ayachi Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 62
male and female participants
aged 20-80 years
with chronic lumbar radicular pain whatever the etiology, defined as pain lumbosacral radicular radiating into the leg below the knee,
which had been present for greater than 3 months,
with VAS pain= 6/10,
and which was not improved by NSAIDs, analgesics and physical treatment.
(1) a specific spinal pathological entity such as infection, inflammatory or tumor pathology, or fractures,
(2) spinal surgery within the last 4 weeks,
(3) a coexisting major disease for which clomipramine may be inappropriate: glaucoma, urinary problems, recent myocardial infarction, convulsions,
(4) any current use of other antidepressants,
(5) current use of recommended full and regular doses of another analgesic,
(6) allergy or contraindication for experimental drugs,
(7) pregnancy, planning or trying to become pregnant or breastfeeding.
All participants will benefit from an initial cardiac evaluation. We will also exclude all subjects with a major cardiovascular risk factor or cardiac pathology with risk of decompensation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pain intensity using a Visual Analog Scale (VAS) of 10 mm, scale where patients will be asked to estimate their current pain, with 0 indicating no pain and 10 indicating the worst pain imaginable
- Secondary Outcome Measures
Name Time Method